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Recall Communications-third party disclosure (including Agency Guidance recommendations)
FDA Recall Regulations
OMB: 0910-0249
IC ID: 215023
OMB.report
HHS/FDA
OMB 0910-0249
ICR 202403-0910-012
IC 215023
( )
Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Recall Communications-third party disclosure (including Agency Guidance recommendations)
Agency IC Tracking Number:
ORA
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Voluntary
CFR Citation:
21 CFR 7.49
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Public Health Monitoring
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
2,309
Number of Respondents for Small Entity:
200
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
95 %
Approved
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
2,558,372
0
0
1,321,717
0
1,236,655
Annual IC Time Burden (Hours)
127,919
0
0
66,086
0
61,833
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
No associated records found
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.